Director, External Large Molecule Analytical

539

**
Bachelor's degree in biology or chemistry with 12 years experience
Experience in biologics or vaccines commercialization
Knowledge of chinese pharmacopoeia and regulatory cmc topics
** The job posting is for a Director of External Large Molecule Analytical role at Merck, focusing on the analytical oversight of large molecule products, particularly in the Chinese market. The position requires extensive experience in biopharmaceuticals, strong technical leadership skills, and the ability to collaborate with various stakeholders. **

Job Summary

  • This role leads global analytical technical oversight for late-stage pipeline programs through commercialization and product lifecycle management.
  • The position requires direct interaction with China's government laboratories such as CDE and NIFDC to ensure uninterrupted supply of biologics.
  • Candidates must facilitate logistics, support test method establishment, and influence updates to regulatory compendia including the Chinese Pharmacopoeia.

Matching Summary

Match Score: 75

** The job posting is for a Director of External Large Molecule Analytical role at Merck, focusing on the analytical oversight of large molecule products, particularly in the Chinese market. The position requires extensive experience in biopharmaceuticals, strong technical leadership skills, and the ability to collaborate with various stakeholders. **

Skills & Requirements

Must-have

  • Bachelor's degree in biology or chemistry with 12 years experience
  • Experience in biologics or vaccines commercialization
  • Knowledge of Chinese Pharmacopoeia and regulatory CMC topics
  • Ability to troubleshoot analytical data and methods
  • Strong cross-functional team leadership skills

Nice-to-have

  • Large molecule method development and validation experience
  • Familiarity with LIMS and Veeva Vault software
  • QC Laboratory Due Diligence experience
  • Proactive service-oriented mindset
  • Experience with deviation management processes

Key Requirements

  • BS/BA + 12 years industry knowledge OR MS + 8 years OR PhD + 4 years
  • Experience in biopharmaceutical manufacturing industry
  • Strong organizational and project management skills

Work Rights

Not specified

Tailored Resume

Cover Letter